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Description

Boehringer Ingelheim is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at our Ridgefield, CT facility.

EACD develops new CMC paradigms for more efficient and effective NCE development (small molecule) and for advancement of new chemical entities (NCE-like) Alternative Medicinal Therapeutic Product (ATMP) such as oligonucleotides. The Associate Director/Senior Associate Director of EACD for drug product (DP) development, will be responsible for leading all DP-related activities within the project(s), in support of CMC development within EACD.

The Associate Director/Senior Associate Director of EACD for drug product develops non-traditional BI CMC project strategies for drug substance and drug product development accessed through external collaborations supplemented by academic resources and some internal BI capabilities when required. He/she is responsible for fiscal and technical delivery of the projects in conjunction with other members of the EADC Dept. He/she represents the drug product on project teams as the EACD Team Member. External investments will be made globally to build cost effective relationships with technically and regulatory competent partners. He/she advances comprehensive EACD strategies for alternative development by incorporating efforts and expertise from a complex matrix of external suppliers and internal partners. He/she builds the EACD network of competencies for design, development, GMP clinical supplies and any delivery systems required for the EACD programs, to drive continuous improvement, and to sustain an innovative portfolio of technologies and processes that will advance new CMC development processes. He/she develops effective partnership and strong internal relationships based on trust, technical competence and effective planning, resource management and communication.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

• Deliver drug product deliverables including formulation, manufacturing process, phase-appropriate stability and GMP CTM manufacturing, regulatory document aurthoring/review, and tech transfer assigned to EACD. Implements innovation strategies that enhance scientific and business value of the Dept and extend its scope of influence within BI.

• Develop appropriate external capabilities (using partners accessed from academic, CRO, CMO, drug delivery and consultant constituencies) that allow virtual provision of drug product, drug delivery technology, etc for NCEs and NCE-like projects.

• Introduce new practices and technologies and lead project/technology transfer to late Development, Operations. Provision of DS/DP supplies and appropriate GxP documentation, supplementary scientific information, for NCEs and ATMPs projects assigned to EACD.

• Ensure compliance with all required training, safety, regulatory, HR, laboratory notebook, intellectual property, GMP’s and GLP’s (where applicable), and corporate ethics and policies.

• Develop budgetary requirements for projects, technology developments; manage and adjust activities to operate within budgetary goals.

• Establish robust interfaces with such resources and with key internal partners (Quality, Legal, HPS) and scientific liaisons from Research and Development. Present and defend strategic positions to bring continuous improvement to our CMC capabilities, scientific acumen and awareness of leading-edge approaches for next generation development. Collaborate effectively with the external global scientific community and supplier organizations.

Requirements

Requirements for Associate Director:

• Master's Degree (e.g. MBA, MSc) or equivalent in chemistry, chemical engineering, or pharmaceutical sciences from an accredited institution, with ten-plus (10+) years of industrial experience; OR

• Ph.D. degree from an accredited institution in chemistry, chemical engineering or pharmaceutical sciences with eight-plus (8+) years of industrial experience in the aspects of drug product development (i.e.: pre-formulation, formulation / process development and manufacturing)

Requirements for Senior Associate Director:

+ Master's Degree in chemistry, pharmaceutical science, analytical chemistry or chemical engineering from an accredited institution or equivalent with 12+ years of experience OR;

+ Ph.D. degree with 10+ years of industrial experience in the chemistry, pharmaceutical science or chemical engineering aspects of drug product development(ie: preformulation, formulation / process development,and manufacturing)

Requirements for Both Levels:

+ Experienced in preclinical formulation, pre-formulation characterization, formulation and process development (QbD), tech transfer and cGMP manufacturing. Experience in oligonucleotide formulation and process development is a plus.

+ Experienced in developing phase-appropriate drug product and manufacturing clinical supply for NEC and/or oligonucleotides.

+ Experienced in authoring and reviewing regulatory documents (IND, IMPD, NDA, etc.) and addressing questions from health authorities.

+ Involvement in managing projects with external CROs and CDMOs/CMOs, building partner relationships with CDMOs/CMOs and external vendors. Proven ability to indirectly/directly manage, lead, and motivate others.

+ Experience managing and directing teams/vendors in process research/development, drug product formulations and clinical GMP CTM manufacturing. Experience working effectively in cross-functional teams comprised of internal and/or external contacts.

+ Demonstrated ability to review and approve GxP documentation and technical reports.

+ Experience authoring publications and delivering oral presentations to both to scientists (internally and externally) and senior level management.

+ Working knowledge of ICH quality guidance, EU and FDA drug manufacturing regulations as related to drug substance.

+ Excellent written and oral communication and negotiating skills.

+ Ability to work a flexible work schedule to accommodate program priorities and international activities as needed.

+ Ability to travel (domestic and international) for business reasons (20-30%).

+ **Onsite/Flex*:** This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.

+ Position will be filled commensurate upon experience

Compensation Data

This position, Associate Director, External Alternative CMC Development (EACD) , offers a base salary typically between $140,000.00 and $222,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.